Apparatus and methods for occluding a hollow anatomical structure

ABSTRACT

A method of occluding an appendage of the heart with a clamp including at least first and second elongate clamping portions, the first and second elongate clamping portions including tissue engaging surfaces that promote tissue ingrowth. The method includes implanting the clamp by positioning the first and second elongate clamping portions on opposite sides of the appendage. At least one of the first or second elongate clamping portions is biased toward the other of the first and second elongate clamping portions to place the clamp into a clamping position on the appendage. Tissue ingrowth into the tissue engaging surfaces retains the clamp in place on the appendage.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of Ser. No. 13/897,694, filed May 20,2013 (now U.S. Pat. No. 9,119,627) which is a divisional of Ser. No.12/632,293, filed Dec. 7, 2009 (now U.S. Pat. No. 8,465,507), which is adivisional of Ser. No. 10/853,928, filed May 26, 2004 (now U.S. Pat. No.7,645,285), the disclosures of which are hereby fully incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates generally to surgical methods andapparatus for occluding a hollow tissue structure, such as whenoccluding vessels, or pedunculated structures such as an appendix, gallbladder or appendages on the heart. More specifically, the presentinvention relates to a method and device for occluding the left atrialappendage of the heart in either an open surgical procedure or minimallyinvasive procedure.

BACKGROUND OF THE INVENTION

Atrial fibrillation is a common cardiac rhythm disorder that affectsmore than two million people each year. Until relatively recently,atrial fibrillation was thought to be a nuisance arrhythmia with fewconsequences. However, recent medical research has uncovered somedevastating complications including cardiomyopathy, congestive heartfailure and stroke.

During atrial fibrillation the upper part of the heart beats (quivers)faster than the rest of the heart. This phenomenon is due to thegeneration of erratic or extra electrical signals which cause the toppart of the heart to quiver rapidly and irregularly (fibrillate) as manyas 300-600 times a minute. However, the entire heart does not beat thatfast. The heart is a muscular pump divided into four chambers, two atriaon the top of the heart and two ventricles on the bottom portion of theheart. Normally, the heartbeat starts in the right atrium when a specialgroup of cells sends an electrical signal. These cells are called thesinoatrial or SA node, sinus node or the heart's “pacemaker”. The signalspreads throughout the atria and to the atrioventricular or AV node. TheAV node connects to a group of fibers in the ventricles that conduct theelectrical signal. The electrical impulse travels via these specializedfibers to all parts of the ventricles. The specialized fibers are alsoknown as the His-Purkinje system. The electrical signal must follow thisexact route for the heart to pump properly. Normally, the heart beats at60-80 times per minute at rest. This number represents the contractionsof the lower heart or ventricles. During atrial fibrillation, electricalsignals from other parts of the heart disrupt the heart's normal rhythmand cause the atria to quiver or beat too fast. However, only a smallnumber of these atrial beats make it through the AV node, which actslike a gate to the ventricles. This is fortunate, because a rapidventricular heartbeat would be much more dangerous and potentiallyfatal. However, some atrial fibrillation does make it through the AVnode making the heart beat faster than normal. An atrial fibrillationattack is usually not life threatening. The most significant danger isstroke.

Blood usually moves completely through the chambers of the heart. Duringatrial fibrillation, the heart is not pumping normally or efficiently.The blood begins to pool in the atria and this stagnation of blood cancause the blood to thicken and form clots. These clots are then ejectedout of the heart and into the bloodstream where they can lodge in thebrain causing a stroke. Atrial fibrillation can make stroke five timesmore likely than in the general population. When the heart experiencesatrial fibrillation there may not be enough blood pumping to the brainor other organs. This can cause dizziness, shortness of breath or organfailure. Untreated atrial fibrillation will also weaken the heart due tophenomenon known as remodeling. The heart, like the rest of the body,adapts to changes. The fast abnormal rhythm in the atria causeselectrical changes, and this can enlarge the heart.

There are three major objectives in the treatment of atrialfibrillation: the restoration of normal sinuous rhythm, control ofventricular rate during atrial fibrillation, and the prevention of bloodclot formation. Some methods of treatment for atrial fibrillationinclude pharmacological therapy, pacemakers, and surgery.

For the prevention of blood clots, research has demonstrated that theanticoagulation warfarin (e.g., Coumadin) is effective in reducing therisk of blood clot formation and stroke but it does not totallyeliminate the risk. An anticoagulant such as warfarin interferes withthe body's natural clotting mechanism. The dosage of warfarin is highlyindividualized and must be carefully monitored with blood tests toensure safety. While this pharmacological treatment may significantlyreduce the risk of stroke, it also increases the risk of bleeding andmay be inappropriate for many atrial fibrillation patients.

As an alternative to pharmacological therapy, there are a few surgicalprocedures that isolate the left atrial appendage from the blood'scirculatory system. The most common approach is to occlude the leftatrial appendage during open-heart surgery. In open heart surgery thepatient is placed on a heart-lung bypass machine and the heart istemporarily isolated from the circulatory system while the surgeonoperates on the heart. The left atrial appendage is a small hollowextension (i.e., a pedunculated structure) formed off the lateral wallof the left atrium. It has been referred to as a small windsock or asmall, flat hollow finger-like protrusion. The left atrial appendageusually contracts with the rest of the left atrium during normal heartfunction thereby continually moving blood throughout the hollowextension. During atrial fibrillation, the left atrial appendage oftenfails to contract thereby allowing the blood to pool inside theappendage, becoming stagnated. As a result, the blood becomes thickerand thrombus or clot formation begins. These clots can be slowly ejectedfrom the left atrial appendage into the left atrium and left ventricle,and then released into the bloodstream thereby becoming an obstructionin the brain or other vascular structures. For this reason, it isadvantageous to prevent these clots from forming and being dislodgedinto the bloodstream. One method of preventing the occurrence of clotsis to occlude the appendage thus preventing blood from entering andforming clots. This also prevents clots already formed in the appendagefrom escaping into the bloodstream. Normally, the occlusion of the leftatrial appendage is performed in conjunction with other procedures suchas a mitral valve replacement or coronary artery bypass procedure andnot as the sole reason for the procedure.

There are several different methods being used today to occlude the leftatrial appendage. One method is percutaneous left atrial appendagetranscathether occlusion. A small occlusion device is deployed from avenous access catheter into the left atrium and blocks the opening intothe atrial appendage. In order to access the left atrium from the venacava's right atrium, the surgeon must go through the atrial wall. Manysurgeons are uncomfortable with making an opening in this wall withoutbeing able to repair it at the end of the procedure. There are alsoissues of placing an occlusion device inside the heart. If the occlusiondevice becomes detached within the heart, the result may be fatal.

Another method of occlusion is placing a loop around the left atrialappendage and cinching it down in a manner similar to a garrote. Whentrying to place a flaccid loop around an irregular pedunculatedstructure, it can be difficult to make certain the loop is positioned atthe base of the appendage. When cinching the loop, it is very easy toover tighten the loop, and this can result in severing the delicateatrial appendage. Even a partial tear can create problems in gettingaccess to repair the tear. This method of occlusion may not always sealthe opening between the appendage interior and the atrium. That is,there may still be a partial opening due to the way the appendage wallcollapses during cinching of the loop. Such a partial opening couldstill allow some flow into and out of the atrial appendage, leading tothe problems mentioned above. In addition, transforming the relativelyflat structure of the appendage onto a round hard mass, as does acinching method, could lead to other problems.

Another method of occlusion is to place a linear surgical stapler at thebase of the appendage and a left atrial wall and stapling the appendageclosed. Due to the limited access, the ability to visualize the entireatrial appendage while placing the stapler in the correct location canbe a problem. It is very difficult to make certain the staple line makesa complete occlusion of the appendage. Again, a partial occlusion of theappendage can still result in the formation and dislodgement of clots.

For the aforementioned reasons, it would be desirable to provideimproved methods and devices to reliably occlude hollow anatomicalstructures, and especially the left atrial appendage of the heartcompletely and safely. Such methods may be performed during anopen-heart surgical procedure such as a valve replacement or coronaryartery bypass. It would also be desirable to provide methods and devicesthat may be used in a minimally invasive procedure while the heart isbeating without placing the patient on a heart-lung bypass machine. Aminimally invasive device would allow access through either anintercostal space between the ribs or a supra and/or sub-xiphoidapproach to gain access to the left atrial appendage. Such devices willallow complete visualization of the left atrial appendage for thesurgeon and permit minor placement adjustments to be made beforepermanent installation is made. The devices would also allow completeocclusion of the left atrial appendage, eliminating the risk of clotsforming in the appendage, traveling throughout the bloodstream, andpossibly lodging in the brain causing a stroke.

SUMMARY OF THE INVENTION

The present invention provides devices and methods for occluding ahollow anatomical structure, such as the left atrial appendage of theheart. Generally, the device comprises a clamp having at least first andsecond clamping portions adapted to be placed on opposite sides of thehollow anatomical structure. At least one of the first and secondclamping portions is movable toward the other of the first and secondclamping portions from an open position into a clamping position toocclude the hollow anatomical structure. The clamp comprises a closed,annular shape configured to surround the hollow anatomical structure inthe open position and then assumes a flattened shape in the clampingposition to occlude the hollow interior of the hollow anatomicalstructure. The first and second clamping portions can further compriseconcave portions curved in opposite directions to form the clamp into agenerally oval shape.

In various embodiments, at least one of the first and second clampingportions is spring biased toward the other of the first and secondclamping portions in the clamping position. In this regard, one clampingportion may be normally spring biased toward the other of the first andsecond clamping portions when the first and second clamping portions arein the open position. Upon release, the spring biased clamping portionmoves toward the other clamping portion into a clamping or occludingposition. In another embodiment, one of the first and second clampingportions is movable toward the other of the first and second clampingportions to an over-center position at which a spring bias takes effectand moves the one clamping portion toward the other clamping portion tothe clamping position.

In another aspect of the invention, the first and second clampingportions have tissue engaging surfaces for engaging the hollowanatomical structure in the clamping position. The tissue engagingsurfaces are roughened and preferably adapted to promote tissueingrowth. The tissue engaging surfaces may be comprised of a fabriccovering on at least one of the first and second clamping portions.Other manners of promoting tissue ingrowth may be used on one or bothclamping portions such as etching and other pore-creating methods suchas metal deposition. Pore size should preferably range from 200-400microns. A protective overmold may be provided of, for example, siliconeto assist with traction if tissue ingrowth feature is not utilized onone or both clamping portions. Alternatively, and if necessary, siliconeovermolding or other protective guards may be used to prevent irritationof surrounding tissue, while clamping areas of the device may bedesigned to promote traction and/or tissue ingrowth such as describedabove.

In another aspect, the first and second clamping portions havecomplementary shapes in cross section such that the complementary shapesfit together in the clamping position. At least one of the first andsecond clamping portions may be convexly curved toward the other of thefirst and second clamping portions in cross section. This feature mayassist with providing more uniform force distribution and/or moresealing force along the length of the clamp.

In another aspect, projections may be provided on at least one of thefirst and second clamping portions. The projections are configured toengage and, optionally, pass through the hollow anatomical structurewhen the clamp is in the clamping position. The projections therebyassist with retention of the clamp on the tissue. To further assist withclamp retention, receiving elements may be provided on the opposingclamping portion to engage and lock with the projections when the clampis in the clamping position. Other types of locking elements may beprovided, such as ratchet elements, undulations on tissue engagingareas, bands on the outside of the clamp or other suitable structure.

The clamp may also have an actuating element configured to move one ofthe first and second clamping portions toward the other of the first andsecond clamping portions. This may, for example, be one or more magneticelements on one or both clamping portions, or a mechanical actuationelement such as a rotating or sliding cam element, or any other suitableactuation mechanism.

The invention also provides apparatus for occluding a hollow anatomicalstructure which includes a clamp delivery and actuation device. In thepreferred embodiment, the delivery and actuation device includes firstand second jaws, and an actuator configured to move at least one of thefirst and second jaws toward the other of the first and second jaws. Theclamp delivery and actuation device preferably includes a pistol gripwith an actuating member configured to be manually depressed to move oneof the first and second jaws toward the other of the first and secondjaws. The first and second clamping portions are secured between thefirst and second jaws and may be moved from the open position to theclamping position by moving at least one of the first and second jaws.This allows the clamp to be repeatedly opened and closed, as necessaryfor repositioning purposes, during the surgical procedure. The clamp maybe secured to the jaws in any suitable manner, such as by using sutureor by using other types of gripping elements. The delivery and actuationdevice preferably carries a mechanism to release the clamp, such as ablade to cut the suture, or a tension member which may be pulled torelease the gripping elements or suture. In the case of using thesuture, the tension member may be used to untie the suture, and may bean end of the suture itself.

The clamp is preferably coupled to the first and second jaws so as topivot about an axis generally transverse to its length. This pivotingaction may take place passively or actively. To provide for active orselective pivoting of the clamp, as may be desired by a surgeon to moreaccurately position the clamp, the delivery and actuation deviceincludes a pivoting mechanism coupled to the clamp and configured topivot the clamp in opposite directions about the axis. The surgeon mayoperate the pivoting mechanism at the proximal or handle end of thedevice.

The invention further provides methods for occluding a hollow anatomicalstructure with an annular clamp having at least first and secondclamping portions. Generally, the method comprises surrounding thehollow anatomical structure with the annular clamp, and then moving atleast one of the first and second clamping portions toward the other ofthe first and second clamping portions to occlude the hollow anatomicalstructure. In the preferred embodiment, the hollow anatomical structureis a pedunculated organ or portion of an organ. Most specifically, it isthe left atrial appendage of a heart. Preferably, the method involvesaccessing the left atrial appendage of the heart by a mini-thoracotomyor by another minimally invasive approach.

The method preferably further comprises engaging a structure configuredto promote tissue ingrowth, such as a fabric covering, with the hollowanatomical structure, and optionally also engaging the anatomical tissuewith projections to promote tissue ingrowth after clamping has takenplace. The clamp may be passively or actively pivoted with respect tothe delivery device prior to the step of moving at least one of thefirst and second clamping portions toward the other. In another aspect,a tissue gripper with flat, paddle-shaped gripper elements is providedand used to gently grasp and pull the tissue through the clamp when theclamp is in the open, annular configuration.

It will be appreciated that various additional aspects of the methodscarried out by the various embodiments of this invention will be readilyapparent based on the use of the devices and components of the clamp andthe delivery and actuation device as described hereinabove and furtherbelow.

The present invention provides improved devices and methods forocclusion of hollow tissue such as the left atrial appendage. Oneadvantage of various embodiments described herein is that the surgeoncan open and close the clamp if needed to change the position of theclamp for a better result prior to release of the clamp onto the tissue.The configuration of the delivery and actuation device is such that thedevice can be used not only in an open surgical procedure, but in aminimally invasive surgical procedure during which, for example, thedevice is placed between or under the patient's ribs for access to theleft atrial appendage. The implantable clamp has a geometry which trapsappendage tissue within an annular opening thereby positively attachingthe clamp to the tissue.

In another embodiment, the invention contemplates an apparatus foroccluding a hollow anatomical structure comprising a clamp delivery andactuation device including a hollow structure containing a clampdeploying member. The apparatus further includes a clamp having at leastfirst and second clamping portions adapted to be placed on oppositesides of the hollow anatomical structure. At least one of the first andsecond clamping portions is movable toward and away from the other ofthe first and second clamping portions between a closed position and anopen position in which the clamp assumes an annular shape. The clamp iscarried within the hollow structure in the closed position and isextendable out of the hollow structure by the deploying member whereuponthe clamp may be actuated to the open position and clamped onto thehollow anatomical structure. This embodiment is especially useful forminimally invasive surgical procedures.

These and other features, objects and advantages of the invention willbecome more readily apparent to those of ordinary skill in the art uponreview of the following detailed description, taken in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of an apparatus constructed inaccordance with the invention including a clamp and a delivery andactuation device.

FIG. 2A is an enlarged side elevational view of the clamp and jaws shownin FIG. 1, with the clamp in an open position.

FIG. 2B is an enlarged side elevational view similar to FIG. 2A, butillustrating the clamp in a closed or clamping position.

FIG. 2C is an enlarged view of encircled portion “2C” of FIG. 2A withthe fabric covering broken away.

FIG. 3 is a top view of the clamp and jaws shown in FIGS. 2A and 2B,illustrating the pivotal action of the clamp.

FIG. 4A is a partially fragmented perspective view illustrating theclamp being applied to the left atrial appendage of the heart.

FIG. 4B is a perspective view similar to FIG. 4A, but illustrating theclamp in a closed position on the left atrial appendage.

FIG. 5 is a perspective view similar to FIG. 4A, but illustrating alateral approach of the clamp onto the left atrial appendage.

FIG. 6A is a cross sectional view illustrating the left atrial appendageand a portion of the heart.

FIG. 6B is a cross sectional view similar to FIG. 6A, but illustratingthe application of a clamp to the left atrial appendage according to theinvention.

FIG. 6C is an enlarged view of the encircled portion 6C shown in FIG.6B.

FIG. 7 is a partially cross sectioned side elevational view of the jawsand clamp shown in FIG. 1, partially sectioned to illustrate a clamprelease feature.

FIG. 7A is an enlarged view of encircled portion 7A shown in FIG. 7.

FIG. 8A is a side elevational view of a clamp and alternative jaworientation for the clamp delivery and actuation device, with the clampshown in an open position.

FIG. 8B is a side elevational view similar to FIG. 8A, but illustratingthe clamp in a closed or clamping position.

FIG. 9 is a disassembled perspective view of an alternative clampaccording to the invention.

FIG. 10 is a cross sectional view illustrating the clamp of FIG. 9applied to the left atrial appendage.

FIG. 11 is a cross sectional view similar to FIG. 10, but illustrating aclamp portion having an alternative cross sectional shape.

FIG. 12 is a partially cross sectioned top view of the distal end of aclamp delivery and actuation device, as well as a clamp, secured to thejaws of the device in one alternative manner.

FIG. 13 is a perspective view of the distal end of a clamp delivery andactuation device, and a clamp, constructed in accordance with anotheralternative embodiment.

FIG. 14 is a top view of the clamp and jaw assembly shown in FIG. 13.

FIG. 15 is a fragmented cross sectional view illustrating the clamp ofFIGS. 13 and 14 in a closed or clamping position on the left atrialappendage.

FIG. 16 is a perspective view of a clamp delivery and actuation devicedistal end, as well as a clamp, having a clamp retaining and releasingfeature constructed in accordance with another embodiment.

FIG. 17A is a transverse cross sectional view illustrating the clamp andgripping elements shown in FIG. 16.

FIG. 17B is a cross sectional view similar to FIG. 17A, but illustratingthe release of one of the gripping elements to thereby release thecorresponding clamping portion into a closed or clamping position.

FIG. 18 is a perspective view illustrating yet another embodiment of aclamp gripping element in accordance with the invention.

FIGS. 18A and 18B illustrate respective top views of the clamp grippingelement in the closed and open positions.

FIG. 19 is a perspective view illustrating an alternative apparatusincluding a clamp and delivery and actuation device.

FIG. 19A is a top view of the distal end of the device shown in FIG. 19.

FIG. 20 is a perspective view of the distal end of the device shown inFIGS. 19 and 19A.

FIG. 20A is a perspective view similar to FIG. 20 but illustrating analternative yoke design for the clamp pivoting mechanism.

FIGS. 21A-21C are respective front elevational views illustrating theoperation of the clamp pivoting mechanism shown in FIG. 20.

FIGS. 22A and 22B are side elevational views of another alternativeclamp constructed in accordance with the invention and, respectively,shown in open and closed positions.

FIG. 23 is a side elevational view of another alternative clamp usingratchet elements to achieve an adjustable closed or clamping position.

FIG. 24 is a side elevational view of another embodiment of a clamphaving a two piece construction and again using ratchet elements toachieve an adjustable closed or clamping position.

FIGS. 25A and 25B illustrate perspective views of another alternativeclamp in the open and closed positions, and using a rotatable camelement to actuate the clamp into the closed position.

FIGS. 26A and 26B illustrate side elevational views of anotheralternative clamp utilizing magnetic elements to move the clampingportions between the open and closed positions.

FIGS. 27A and 27B illustrate another alternative clamp, respectively, inthe open and closed positions and using a linear tension element to movethe clamp from the open to the closed position.

FIGS. 28A and 28B illustrate another alternative clamp, respectively, inthe open and closed positions and comprised of a rigid clamping portionand a leaf spring clamping portion.

FIG. 29 is a perspective view illustrating a gripper assembly used topull the hollow anatomical structure through a clamp constructed inaccordance with the invention.

FIG. 30A is a cross sectional view illustrating the distal end of analternative apparatus constructed in accordance with the inventionincluding a clamp and a delivery and actuation device which mayinitially contain and then deploy and actuate the clamp.

FIG. 30B is a cross sectional view similar to FIG. 30A, but illustratingthe clamp fully deployed into an open position around a hollowanatomical structure.

FIG. 30C is a cross sectional view similar to FIG. 30B, but illustratingthe clamp actuating procedure employed by retracting the clamp into thedelivery and actuation device.

FIG. 30D is a cross sectional view similar to FIG. 30C, but illustratingthe clamp in its fully clamped or closed position on the hollowanatomical structure.

FIG. 31 is a cross sectional view taken along line 31-31 of FIG. 30C.

FIGS. 32A and 32B are perspective views illustrating respective engagedand disengaged positions of the delivery and actuation device and theclamp.

DETAILED DESCRIPTION

Referring initially to FIGS. 1, 2A, 2B and 3, a first embodiment of theinvention includes an apparatus 10 comprising a clamp 12 havingrespective first and second clamping portions 12 a, 12 b secured betweenfirst and second jaws 14, 16. A delivery and actuation device 20 carriesfirst and second jaws 14, 16 for actuating clamp 12 between open andclosed or clamping positions as will be described further below. Clampportions 12 a, 12 b are secured to jaws 14, 16 by respective sutures 22a, 22 b. Delivery and actuation device 20 includes a pistol grip 24having a stationary handle 26 coupled with an elongate jaw supportmember 27. A movable handle 28 is coupled with an actuating bar 30 andpivots with respect to stationary handle 26 at a pivot member 32. Whenmovable handle 28 is depressed toward stationary handle 26, this actiondraws actuating bar 30 to the left as viewed in FIG. 1. Actuating bar 30has a connecting portion 30 a secured to respective rigid wire members36, 38. Wire members 36, 38 are secured to jaws 14, 16 such that whenwire members 36, 38 are pulled by actuating bar 30, jaws 14, 16 pivottoward each other about pivot member 34. This moves clamping portion 12a to an over-center position with respect to clamping portion 12 bwhereupon clamping portion 12 a snaps into the clamping position shownin FIG. 2B.

Thus, it will be appreciated that the clamp 12 changes from thegenerally oval, annular (i.e., closed ring-shape) shape shown in FIG. 2Ato the flattened, curved shape shown in FIG. 2B when moving from theopen to the closed position. It will also be appreciated with respect tothis embodiment and others disclosed herein that clamp 12 may berepeatedly opened and closed by device 20. This can allow repositioningof clamp 12, as necessary, during the surgical procedure prior torelease of clamp 12 from device 20. FIG. 3 further illustrates thatclamp 12 is pivotal about an axis extending transverse to the length ofclamp 12 in opposite directions as shown by arrows 40, 41. This pivotingaction is a passive pivoting action. That is, clamp 12 may freely pivotfrom the generally straight orientation shown in solid lines to therespective oppositely angled orientations shown in dash-dot lines.

FIG. 2C illustrates, in enlarged detail, an end portion of clamp 12 witha fabric covering 60 partially removed to reveal leaf spring members 56,58, which operate as will be discussed below. As shown in FIG. 2C, leafspring member 56 includes a rounded end portion 56 a which is designedto protect the patient from irritation which may have otherwise beencaused by exposed sharp edges of leaf springs 56, 58. FIG. 2C alsoillustrates an end portion 58 a of leaf spring member 58 which is angledrelative to the remaining portion of leaf spring member 58 and ispositioned inside of rounded end portion 56 a. A stop tab 61 is alsoformed in rounded end portion 56 a, such as through a stampingoperation. As leaf spring member 58 moves from the open position (shownin solid lines) to the closed position (shown in dash-dot lines), angledend portion 58 a will rotate against and finally stop behind tab 61 tolock leaf spring member 58 a in the closed position.

FIGS. 4A and 4B partially illustrate the chest anatomy of a patientcomprising ribs 44 and a heart 48 including a left atrial appendage 50.In one approach using the present invention, clamp 12 may be deliveredmedially between respective ribs 44 through, for example, a thoracotomyand intercostal space. In this regard, a relatively small incision (notshown) is made between ribs 44 and clamp 12, jaws 14, 16 and elongatejaw support member 27 are directed between ribs 44 through the incision.The opened clamp 12 may be placed around left atrial appendage 50 suchthat clamping portions 12 a, 12 b, which form an annular shape, surroundleft atrial appendage 50 as shown in FIG. 4A. As further shown in FIG.4B, when jaws 14, 16 are actuated to a closed position as previouslydescribed, clamping portions 12 a, 12 b move together essentially asshown to clamp and close off or occlude left atrial appendage 50.

FIG. 5 illustrates one of several other approaches which may be usedwith the present invention. In this regard, clamp 12, jaws 14, 16, andelongate jaw support member 27 may be introduced in an intercostal spacebetween a patient's ribs 44 using a lateral approach to thereby accessthe left atrial appendage 50. After suitably angling clamp 12 andsurrounding left atrial appendage 50 with clamping portions 12 a, 12 b,jaws 14, 16 may be actuated as previously described to bring clampingportions 12 a, 12 b together and close off left atrial appendage 50. Itwill be appreciated that a sub-xiphoid approach may also be used, aswell as several other approaches, such as open surgical approaches usedduring open heart surgery.

FIGS. 6A, 6B and 6C illustrate schematic cross sections of a portion ofheart 48. In particular, left atrial appendage 50 is shown in crosssection to illustrate its hollow interior 52 which communicates with theleft atrium 54 of heart 48. FIG. 6A illustrates the normal configurationof left atrial appendage 52. FIG. 6B illustrates clamp 12 in place, withFIG. 6C illustrating the same in enlarged detail. As shown in FIGS. 6Band 6C, clamping portions 12 a, 12 b respectively comprise clamp members56, 58, at least one of which acts as a leaf spring member, and having afabric covering 60 thereon. Fabric coverings may be treated withcollagen, albumin, etc., to promote tissue ingrowth 64, 66. Fabrics suchas DACRON polyester or expanded polytetrafluoroethylene may be used inthis regard to promote inflammatory response and tissue ingrowth. Suchtissue ingrowth 64, 66 will then assist with retaining clamp 12 inplace. Clamp 12 may be placed extremely close to the outer surface 54 aof left atrium 54 to ensure that there is very little void space atjunction 68 (FIG. 6C). Elimination of void space is important, forexample, to ensure that blood clots do not form from stagnant blood.

FIGS. 7 and 7A illustrate one embodiment of a mechanism used forreleasing clamp 12 from jaws 14, 16. Specifically, sutures 22 a, 22 bmay be tied through apertures 70 a, 70 b. Respective tension members 72a, 72 b are coupled to blades 74 a, 74 b. When tension members 72 a, 72b are pulled proximally (see arrow 76 in FIG. 7A), blades 74 a, 74 bmove past apertures 70 a, 70 b and cut sutures 22 a, 22 b. Optionally,sutures 22 a, 22 b may be formed as a single suture such that a singleblade may be used to release the clamp 12 and the entire suture may bethen carried out of the patient with one of the jaws 14, 16. In theembodiment shown, in which both sutures 22 a, 22 b are cut, the sutures22 a, 22 b may, for example, remain tied to clamp portions 12 a, 12 b.

FIGS. 8A and 8B respectively illustrate the open and closed positions ofan alternative apparatus 10′ constructed in accordance with theinvention. In this embodiment, like reference numerals are used toindicate like components of the first embodiment described above.Therefore, these like components need no additional explanation.Components having reference numerals with prime marks (′) indicatecomponents which have been slightly modified in this embodiment as willbe apparent. In this regard, all components of apparatus 10′ may be asdescribed previously, except that jaws 14′, 16′ are angled such thatthey hold clamp 12 at an acute angle a relative to the axis of elongatejaw support member 27. That is, the length of clamp 12 extends along anaxis 78 which forms an angle of in the range of approximately 20° -30°with respect to axis 79 of elongate jaw support member 27. This angleddelivery orientation of clamp 12 has been found to enable easierapplication of clamp 12 to the left atrial appendage 50 (FIG. 4A). Anadditional angle γ may also be utilized as viewed from the top anddiscussed relative to FIG. 19A below. In all other respects, theoperation of apparatus 10′ may be the same as described above.

FIGS. 9 and 10 illustrate one alternative embodiment of a clamp 80constructed in accordance with the invention. In this regard, clamp 80may be comprised of two separate clamping portions 80 a, 80 b, at leastone of which acts as a leaf spring member. Clamping portion 80 aincludes slots 82, 84 which receive respective connecting tabs 86, 88 ofclamping portion 80 b. In this manner, a generally oval annular shape isobtained when clamping portion 80 a is connected to clamping portion 80b. Clamping portions 80 a, 80 b may be covered with a fabric or othersuitable coating for promoting tissue ingrowth as previously describedand/or for traction purposes. FIG. 9 further illustrates undulating,stamped or molded side edges 85, 87 which also may be consideredprojections to prevent clamp movement or migration. This may be combinedwith a tissue ingrowth feature as mentioned herein. Alternatively, or inaddition, the clamps of this invention may have a resilient polymericcoating on one or both clamping portions to promote traction. Forexample, the polymeric material may be silicone. As illustrated in FIG.10, clamping portion 80 a is flat in cross section, while clampingportion 80 b is circular in cross section. This provides for moreuniform and efficient force distribution along the length of clamp 80 inthe closed position as shown in FIG. 10 when clamping off the leftatrial appendage from the left atrium as previously described. Siliconecoatings 81 a, 81 b are used for traction, i.e., to prevent slippage ofclamp 80. The interior 52 of left atrial appendage 50 is thereby closedoff completely from the left atrium 54 such that residual pockets whichcan trap stagnant blood are minimized or eliminated.

FIG. 11 illustrates a cross section similar to FIG. 10 but showing analternative clamping portion 80 a′ which has been slightly modified tohave a concave surface in cross section facing the convex outer surfaceof clamping portion 80 b. This design can promote a better fit betweenclamping portion 80 a′ and clamping portion 80 b to ensure bettersealing and potentially less void space at junction 68.

FIG. 12 illustrates a top, partial cross sectioned view of analternative apparatus 90 constructed in accordance with the invention.Apparatus 90 may be constructed the same as the first describedembodiment in all respects except for the manner of securing clamp 12 tojaws 14, 16 (only one shown in FIG. 12). In this regard, a suture 92 istied with a suitable slip knot 94 such that the ends 92 a of suture 92may be pulled to release clamp 12 from jaws 14, 16. It will beappreciated that a slip knot similar to slip knot 94 may be used tosecure each clamping portion, although only one slip knot 94 andclamping portion 12 a are shown in FIG. 12. Alternatively, suture 92 maybe secured by only one slip knot 94 with a portion of the suture 92extending around and coupling suitably with the opposite clampingportion 12 b (not shown).

FIGS. 13-15 illustrate another alternative embodiment of an apparatus100, again only showing the distal end of apparatus 100 in FIGS. 13 and14. The portions not shown may be constructed and operated similarly tothe previously described embodiments. In this embodiment, apparatus 100includes a clamp 102 with first and second clamping portions 102 a, 102b, which may or may not be covered with fabric, but which areillustrated as curved leaf spring members in FIGS. 13 and 14, without afabric covering for clarity. In this embodiment, suture material 104extends through respective curved slots 106 a, 106 b, 108 a, 108 b ineach clamping portion 102 a, 102 b with the curved slots 106 a, 106 b,108 a, 108 b thereby allowing for pivoting action in the jaws 107, 109as previously described with respect to jaws 14, 16 of the firstembodiment and as shown best in FIG. 14. Also in this embodiment, aplurality of projections 110 are provided on one of the clampingportions 102 b and are received by respective aligned apertures 112formed in the opposite clamping portion 102 a when in the closed orclamping position as shown in FIG. 15. Collapsible sleeves 114 may beplaced around the projections 110 so as to prevent snagging on tissueduring delivery and application of the clamp 102 to the tissue such asthe left atrial appendage 50. In this embodiment, to release the clamp102 from the jaws 107, 109, the suture material 104 may simply be cut atthe proximal end (not shown) and then carried out with the apparatus 100after application of the clamp 102 to the tissue (appendage 50). Asshown in FIG. 15, the projections 110 will extend through the fabriccovering 102 c, the tissue, and the receiving element or aperture 112 inthis case when the clamp 102 is in the closed or clamping position. Thisnot only assists with securing the clamp 102 in the closed position, butalso further promotes tissue ingrowth as a small amount of bleeding willoccur because of the penetration of the projection 110 and this bleedingcan promote tissue ingrowth into the fabric covering 102 c.

FIGS. 16, 17A and 17B illustrate another alternative apparatus 120constructed in accordance with the invention. In this embodiment, analternative mechanism is provided for securing and releasing a clamp 122to and from the jaws 124, 126. In this regard, gripping elements 128,130 are provided in the form of spring loaded fingers which are normallybiased to the open position shown in the upper portion of FIG. 17B. Acam-type recess 132, 134 receives each gripping element 128, 130 suchthat the fingers are drawn together around the respective clampingportions 122 a, 122 b as shown in FIG. 17A. Small diameter rods 136, 138are placed through respective eyelets 140, 142 and 144, 146 to hold thefingers together. When rod 136 is removed from the corresponding eyelets140, 142 as shown in the upper portion of FIG. 17B, the eyelets 140, 142spread apart and the gripping element 128 biases itself out of thecam-type recess 132 into an open position. In this embodiment, thisrelease may then allow the normally closed clamp 122 to assume itsclosed position around the tissue 148 through biased movement ofclamping portion 122 a toward portion 122 b. Once the tissue 148 hasbeen clamped as shown in FIG. 17B, the opposite gripping element 130 maybe released from clamping portion 122 b in the same manner, whereuponthe apparatus 120 may be withdrawn from the patient.

FIGS. 18, 18A and 18B illustrate another alternative clamp portiongripping element 150 having a pair of fingers 152, 154 which engage theclamping portion 156 in a manner similar to the gripping elementsdisclosed in FIGS. 16, 17A and 17B. As with the embodiment of FIGS. 16,17A, and 17B, the gripping elements are carried as separate pieces on,or formed as part of, the jaws (e.g., jaws 14, 16). Fingers 152, 154 arenormally closed as shown in FIG. 18A to firmly hold the clamping portion156 therebetween, but may be opened by drawing a tension member 160 andball or wedge member 162 rearward as shown in FIG. 18B. In this manner,one clamp portion may be released at a time in a manner similar to thatdescribed in connection with FIGS. 16, 17A and 17B. If the jaws areactuated to move one of the clamping portions to an over center positionrelative to the other clamping portion as previously described, then therelease mechanism shown in FIGS. 18, 18A and 18B may release bothclamping portions at the same time after the clamping operation hastaken place.

Referring now to FIGS. 19, 19A and 20, an alternative embodiment of anapparatus 200 is shown in which like reference numerals refer to likecomponents of the first embodiment and reference numerals having prime(') marks refer to components which have been slightly modified relativeto the corresponding components in the first embodiment, as will beapparent. Apparatus 200 comprises a clamp delivery and actuation device202 having an elongate jaw support member 27′ with a clamp pivotingmechanism 204 at one end, including a rotatable actuating member 206.Rotatable actuating member 206 serves to rotate a rod (FIG. 20) back andforth via a suitable gear arrangement (not shown) or direct coupling tothereby rotate a yoke 210 back and forth. Yoke 210 is coupled with oneend of clamp 12 and, therefore, rotation of yoke 210 back and forthpivots clamp 12 back and forth through a desired angle as shown in FIGS.21A-21C. This angle may, for example, be in the range of about 10° toabout 40°.

Apparatus 200, and specifically delivery and actuation device 202,includes a pistol grip handle 24′ having a stationary handle portion 26′and a movable handle portion 28 coupled to stationary handle portion 26′by a pivot 32. Stationary handle portion 26′ is coupled to the proximalside of pivoting mechanism 204. A stationary jaw 216 and a movable jaw218 are coupled to the distal end of elongate jaw support member 27′.Clamp 12 is secured to jaws 216, 218 by suture material 220, 222 using aslip knot configuration as previously described such that when theexposed ends of suture material 220, 222 are pulled at the proximal endof apparatus 200, clamp 12 is released from jaws 216, 218. A link 230 ispivotally coupled to jaw 218 at a pivot 232, and jaw 218 is furtherpivotally coupled to elongate jaw support member 27′ at a pivot 234. Anactuation bar or rod 236 is pulled proximally when the surgeon squeezeshandle portion 28 toward stationary handle portion 26′. This causes jaw218 to pivot upwardly relative to stationary jaw 216 to close clamp 12as previously described. Jaw 218 may likewise be moved away fromstationary jaw 216 by moving handle portion 28 away from stationaryhandle portion 26′ to thereby open clamp 12 if, for example, necessaryto reposition clamp 12 on the tissue (not shown). As further shown inFIG. 19A, jaws 216, 218 are angled relative to the longitudinal axis ofelongate jaw support member 27′ by an angle y as viewed from the top.This assists with positioning clamp 12 relative to the left atrialappendage. This may also be coupled with the upward angle as shown, andas more specifically described in connection with FIGS. 8A and 8B above.

FIG. 20A illustrates an alternative embodiment which is the same as FIG.20 but uses a yoke 210′ in the shape of a closed loop instead of aforked yoke 210.

FIGS. 22A-28B illustrate various alternative clamps constructedaccording to the invention. More specifically, FIGS. 22A and 22Billustrate respective first and second clamping portions 1200, 1202which may be actuated from an open position as shown in FIG. 22A, to aclosed position, as shown in FIG. 22B, by sliding cam elements 1204,1206 moving in the direction of arrows 1208 and locked in recesses 1211,1213. This may be done by pulling tension members 1205, 1207. FIG. 23illustrates a one piece clamp 1210 which may be moved from an openposition as shown in solid lines to a closed position as shown indash-dot lines and locked in place by respective ratchets 1212 at anappropriate clamping position. FIG. 24 is similar to FIG. 23, butillustrates a two piece clamp 1220 having first and second clampingportions 1220 a, 1220 b each locked in place on the other clampingportion by respective ratchets 1222 a, 1222 b. FIGS. 25A and 25Billustrate a clamp 1230 having first and second clamping portions 1230a, 1230 b movable from the open position shown in FIG. 25A to the closedposition shown in FIG. 25B. Rotatable cam elements 1232, 1234 arepivotally connected to the clamping portions 1230 a, 1230 b and areengageable with containment members 1236, 1238 coupled with clampingportions and having surfaces engaged with the cam elements 1232, 1234during rotation thereof. Rotation of cam elements 1232, 1234 againstcontainment members 1236, 1238 by pulling tension members 1233, 1235forces the flexible clamping portions 1230 a, 1230 b together as shownin FIG. 25B. FIGS. 26A and 26B illustrate a clamp 1240 with respectivefirst and second clamping portions 1240 a, 1240 b movable together bymagnetic attraction which may, for example, be brought about bypermanent magnets 1242, 1244 as shown, or by an electromagnetic device(not shown). In addition, one or both clamping portions 1240 a, 1240 bmay act as a leaf spring as previously described. FIGS. 27A and 27Billustrate a clamp 1250 having first and second clamping portions 1250a, 1250 b and activated by drawing respective tension member portions1252, 1254 against raised elements 1256, 1258 secured to each clampingportion 1250 a, 1250 b. Ratchet type locking elements 1255, 1257 may beused to retain tension member portions in the clamping positions shownin FIG. 27B. FIGS. 28A and 28B illustrate another clamp 1260 comprisedof a leaf spring clamping portion 1260 a and a rigid clamping portion1260 b. Leaf spring 1260 a may be depressed relative to rigid member1260 b whereupon it snaps into place to clamp the tissue therebetween.

FIG. 29 illustrates the distal end of a paddle type gripper device 1300which may be used to pull tissue, such as the left atrial appendage,through a clamp as described herein. More specifically, device 1300includes a paddle type pivoting gripper 1302 at the distal end thereof.Gripper 1302 includes an elongate support member 1304 with first andsecond gripper members 1306, 1308 at the distal end, at least one ofwhich moves toward the other to grip tissue (not shown) therebetween. Inthe embodiment shown, these flat paddle like gripper elements 1306, 1308include knobbed tissue engaging surfaces 1310, 1312 to gently but firmlyenable gripping of delicate tissue, such as tissue of the left atrialappendage. Gripper elements 1306, 1308 are actuated toward each other toa closed position in a manner similar to the jaws disclosed above in thefirst embodiment of apparatus 10. More specifically, gripper elements1306, 1308 include proximal end portions 1314, 1316 pivoted in ascissor-type fashion to elongate support member 1304 at a pivot 1315. Anactuating rod 1318 is pulled proximally, such as through the use of apistol grip construction as previously described, and is coupled towires 1320 (only one shown) which are respectively coupled to proximalend portions 1314, 1316. In this manner, gripper elements 1306, 1308 maybe repeatedly closed and opened to gently grip and pull tissue through aclamp, such as disclosed hereinabove.

Referring to FIGS. 30A-30C, an apparatus 1400 is shown and includes aclamp delivery and actuation device 1402 configured to internally carry,deploy and then actuate a clamp 1404 onto a hollow anatomical structure1405. Clamp 1404 includes respective clamping portions 1404 a, 1404 bhaving respective rails 1406, 1408 carried thereon, such as by beingintegrally molded therewith or otherwise secured thereto. Rails 1406,1408 ride on respective guide members 1410, 1412, as best shown in FIG.31, for purposes as will be described. Device 1402 includes a tube 1420which may have a diameter sized for minimally invasive surgery (e.g., 8mm) and which carries a first rod or clamp deployment member 1422preferably in the form of a piston-type member which reciprocates withinthe interior of tube 1420. O-rings 1424, 1426 or similar elements may beused to provide some frictional resistance and better control to thereciprocating motion of rod 1422. A gripper 1430 is carried forreciprocating movement with rod 1422 and is used to grasp clamp 1404 asshown in FIGS. 30A-30C, as well as in FIGS. 31 and 32A. A tube 1432 isalso carried by rod 1422 and holds gripper 1430. Tube 1432 may be usedto open and close gripper elements 1430 a, 1430 b (FIGS. 31, 32A-B) andalso to push clamp 1404 out of tube 1420 during deployment of clamp 1404as described below. As further shown in FIG. 32B, when tube 1432 isretracted, or pulled to the left with respect to gripper 1430, gripperelements 1430 a, 1430 b will spring apart into their normally biasedopen or disengaged position. At this point, clamp 1404 may be disengagedfrom delivery and actuation device 1402. Pushing tube 1432 in theopposite direction into the position shown in FIG. 32A will closegripper elements 1430 a, 1430 b. It will be appreciated that othermanners of securing clamp 1404 for movement with respect to device 1402may be used instead.

More specifically referring to FIG. 30A, clamp 1404 may be initiallyfully contained within tube 1420, in a closed position, although FIG.30A shows clamp 1404 partially deployed. As clamp 1404 is pushedentirely out of the distal end of tube 1420, the clamp will be opened asshown in FIG. 30B since the path along which the rails 1406, 1408 movealong guides 1410, 1412 forces clamping portion 1404 a past anover-center position at which clamping portion 1404 a will snap into theopen position shown. The combined delivery and actuation device 1402 andclamp 1404 may be initially delivered in a compact state through a smallincision in the patient. Once the distal end of apparatus 1400 isinserted in this fashion, deployment may take place as shown in FIG. 30Band described above. Once the hollow anatomical structure 1405 ispositioned between clamping portions 1404 a, 1404 b as shown in FIG.30B, clamp 1404 may be withdrawn into tube 1420. A compression member1434 will deform clamping portion 1404 a past an over-center positiontoward the closed position whereupon clamping portion 1404 a will snapinto the closed position shown in FIG. 30D. At this point, tube 1432 maybe retracted to the left as shown in FIGS. 30D and 32B thereby releasinggripper 1430. As slots 1436, 1438 (FIG. 31) are formed on opposite sidesof tube 1420, the hollow anatomical structure 1405 may be initiallyretracted into tube 1420 during the clamping process. As rails 1406,1408 disengage their respective guide members 1410, 1412 as shown inFIG. 30D, delivery and actuation device 1402 may be withdrawn from thepatient leaving the clamp 1404 and hollow anatomical structure 1405 inplace. As further shown in dash-dot lines in FIGS. 32A and 32B, clamp1404 may have a fabric covering 1440 which, preferably, is adapted topromote tissue ingrowth as previously discussed. This embodiment isespecially adapted for use in minimally invasive surgical procedures.For such purposes, the maximum outer diameter of tube 1420 is preferablyabout 12 mm, although various cross sectional shapes may be used havingouter diameters from, for example, about 8 mm to about 12 mm.

While the present invention has been illustrated by a description ofvarious preferred embodiments and while these embodiments have beendescribed in some detail, it is not the intention of the Applicants torestrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. The various features of the invention may beused alone or in numerous combinations depending on the needs andpreferences of the user. This has been a description of the presentinvention, along with the preferred methods of practicing the presentinvention as currently known.

What is claimed is:
 1. A method of occluding an appendage of the heartwith a clamp having at least first and second elongate clamping portionsconfigured to be implanted and placed on opposite sides of the leftatrial appendage, at least one of the first and second clamping portionsbeing movable toward the other of the first and second clamping portionsfrom an open position into a clamping position to occlude the leftatrial appendage, and having first and second ends spaced apart fromeach other along a longitudinal direction of the clamp, the first andsecond clamping portions joined together proximate the first and secondends, whereby the first and second clamping portions and the first andsecond ends define a closed shape, and a fabric covering on the firstand second clamping portions, the fabric covering extending completelyaround an outer peripheral surface of each of the first and secondclamping portions and the first and second ends, the method comprising:implanting the clamp by positioning the first and second elongateclamping portions on opposite sides of the appendage; biasing at leastone of the first or second elongate clamping portions toward the otherof the first and second elongate clamping portions to place the clampfrom the open position into the clamping position on the appendage andthereby occlude the appendage; and promoting tissue ingrowth into thefabric to retain the clamp in place on the appendage.
 2. The method ofclaim 1, wherein the method further comprises: accessing the appendageof the heart through an intercostal space of a patient.
 3. The method ofclaim 1, further comprising: moving at least one of the first and secondelongate clamp portions away from the other of the first and secondelongate clamping portions; repositioning the clamp on the appendage;and moving at least one of the first or second elongate clampingportions toward the other of the first and second elongate clampingportions to occlude the appendage.
 4. The method of claim 1, furthercomprising: delivering the clamp in proximity to the appendage with adelivery device; and pivoting the clamp with respect to the deliverydevice prior to occlude the appendage.
 5. The method of claim 1, furthercomprising: engaging the appendage on opposite sides with straight linecontact between the first and second elongate clamping portions and theopposite sides of the appendage.
 6. The method of claim 1, whereinbiasing at least one of the first or second elongate clamping portionsfurther comprises: using a biasing element positioned proximate each oftwo opposite ends of the first and second elongate clamping portions tobias the first and second elongate clamping portions toward each otherand against the opposite sides of the appendage.
 7. The method of claim1, further comprising: attaching the clamp to a delivery device;delivering the clamp in proximity to the appendage with the deliverydevice; and detaching the clamp from the delivery device.